Identity
- Trade Name
- Celluma FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- 3 mode large panel FDA UDI
- Model / Reference
- iPRO C/US FDA UDI
- Description
- 3 mode large panel FDA UDI
Identifiers
- Catalog Number
- COTB-001 FDA UDI
- Primary DI / UDI-DI
- 00850523007174 FDA UDI
- 510(k) Number
- K171323 FDA UDI
- FDA Product Code
- OLP FDA UDIOHS FDA UDIILY FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blue/red/infrared phototherapy lamp
Celluma by BioPhotas, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171323 also covers:
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
- Celluma — BioPhotas, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- BioPhotas, Inc.
Sources (1)
- FDA UDI ce1a78cc-1b8b-4f7e-b0e9-af122d92d688 35 fields · synced Jun 1, 2026